TECHNICAL FIELDThe field of art to which this invention relates is arthroscopic surgical procedures, in particular, arthroscopic surgical procedures for replacing an anterior cruciate ligament in the knee.
BACKGROUND OF THE INVENTIONArthroscopic surgical repairs of a ruptured anterior cruciate ligament in the knee are known in this art. A rupture of the anterior cruciate ligament (“ACL”) is often seen in sports related injuries. In a typical arthroscopic procedure, the surgeon prepares the patient for surgery by insufflating the patient's knee with sterile saline solution. Several cannulas are inserted into the knee and used as entry portals into the interior of the knee. A conventional arthroscope is inserted through one of the cannulas so that the knee may be remotely viewed by the surgeon. The surgeon then drills a tibial tunnel and a femoral tunnel in accordance with conventional surgical techniques using conventional surgical drills and drill guides. A replacement anterior cruciate ligament graft is then prepared and mounted in the tibial and femoral tunnels, and secured using conventional techniques and known devices in order to complete the ACL reconstruction.
Several types of anterior cruciate ligament grafts are available for use by the surgeon in ACL reconstruction procedures. The grafts may be autografts that are harvested from the patient, for example patellar bone-tendon-bone grafts, or hamstring grafts. Or the grafts can be xenografts, allografts, or synthetic polymer grafts.
There are various known methods for securing the femoral end of an ACL graft in the femoral tunnel. The methods include, for example, cross-pinning, and the use of femoral tunnel interference screws. Of particular interest is a procedure wherein a cross-pin is used to secure the graft in the femoral tunnel. When such a device is used, a transverse tunnel is drilled into a section of the femur such that it intersects the longitudinal femoral tunnel. When using a conventional cross-pinning technique, the surgeon typically prepares the graft by forming or folding it into a loop. Typically, this step is preceded by whip stitching the ends of the graft in a conventional manner. After the top end of the graft loop is emplaced in the femoral tunnel, a cross-pin is then inserted into the transverse tunnel and through the opening in the loop of the graft underneath the top of the graft, thereby both securing the graft in place in the femoral tunnel.
Although the existing methods of performing ACL reconstruction using cross-pins are satisfactory for their intended purpose, and provide the patient with the desired therapeutic result, there is a constant need in this art for improved methods of performing ACL graft reconstruction using cross-pins. In particular, one critical aspect of a cross-pinning method is the ability to place a graft in a femoral tunnel such that when the cross-pin is inserted through the transverse tunnel, the pin is precisely placed in the opening of the graft loop below the top of the graft loop. It can be appreciated by those skilled in this art that placement of the cross-pin above the top of the graft loop will result in the graft not being adequately secured in the femoral tunnel, with the likelihood of a catastrophic failure. Precise placement of a cross-pin into the opening of a graft loop is presently accomplished in this art by using guide wires and cannulated cross-pins that are inserted over the guide wires. In one known method, a guide wire consisting of a flexible filamentary member is actually looped through the transverse tunnel and down through the femoral and tibial tunnels, such that an end extends out through both sides of the transverse tunnel, and a bottom loop extends out through the bottom of the tibial tunnel. A graft is folded to form a graft loop and placed about the bottom loop of the guide wire such that the guide wire runs through the graft loop opening. The ends of the guide wire extending out through the openings of the transverse tunnel are tensioned to pull the guide wire and graft up through the tibial and femoral tunnels into a desired position for fixation, and a cannulated cross-pin is then threaded over the guide wire and mounted in the transverse tunnel to secure the upper part of the graft loop in the femoral tunnel. Although this method succeeds in emplacing a graft in the femoral tunnel and securing it with a cross-pin, there are disadvantages associated with its use. For example, it requires that the graft be pulled longitudinally through the tibial and femoral tunnels by pulling transversely on the flexible filamentary member ends that exit the sides of the transverse tunnel. This may result in damage to the bone surrounding the interiors of the femoral and transverse tunnels. In addition, it can be a lengthy and time-consuming process since it is inefficient to move a graft longitudinally through a tunnel by pulling transversely on the flexible filamentary member.
Accordingly, there is a need in this art for improved methods of ACL knee reconstruction using cross-pins.
SUMMARY OF THE INVENTIONIt is an object of the present invention to provide a novel method of performing an ACL reconstruction using a cannulated cross-pin, wherein a filamentary member is provided as a guide for the cross-pin, and an ACL graft is pulled into the tibial and femoral tunnels using a surgical needle and attached surgical suture.
Therefore, a method for repairing a knee arthroscopically using an anterior cruciate ligament replacement graft is disclosed. The method consists of providing an anterior cruciate ligament replacement graft that is formed into a loop having a top and a bottom. The loop has an opening. A longitudinal tibial tunnel is drilled through a top of a tibia adjacent to the knee, the tibial tunnel has top and bottom openings. A longitudinal femoral tunnel is drilled through the bottom section of an adjacent femor such that the tibial tunnel and the femoral tunnel are substantially in alignment. The femoral tunnel has opposed top and bottom openings. A substantially transverse tunnel is drilled through the femoral tunnel such that the transverse tunnel intersects the femoral tunnel and is in communication therewith, the transverse tunnel has opposed first and second openings. A filamentary member is provided. The filamentary member is an endless loop. The filamentary member is threaded through knee such that a first end loop of the filamentary member extends out from a first side of the transverse tunnel, continues through the femoral and tibial tunnels, and a second end loop extends out through the bottom opening of the tibial tunnel. A surgical needle and suture are provided. The suture is mounted to the surgical needle such that a suture loop is formed. The graft is engaged with the suture loop such that the suture passes through the graft loop opening. And, the graft is also engaged with the second end loop of the filamentary member such that the filamentary member passes through the graft loop opening. The needle and suture are moved into the tibial tunnel and femoral tunnel. The graft loop is pulled into and partially out of the tibial tunnel by pulling on the needle and suture, such that the top of the graft loop is located outside of the top opening of the tibial tunnel and adjacent to the bottom opening of the femoral tunnel. The needle and suture move out through the top opening of the femoral tunnel. The filamentary member simultaneously moves with the graft as the suture is pulled. The second end loop of the filamentary member is also located outside of the top opening of the tibial tunnel adjacent to the bottom opening of the femoral tunnel. The first end loop of the filamentary member is then cut to form first and second ends. The first end of the filamentary member is maintained outside of the first opening of the tibial tunnel, and the filamentary member is manipulated to extend through the transverse tunnel with the second end of the filamentary member extending out through the second opening of the transverse tunnel. The suture is then tensioned to move the top of the graft loop and the second end loop of the filamentary member into to femoral tunnel such that the graft loop opening is in substantial alignment with the transverse tunnel. The filamentary member is tensioned to form a substantially straight configuration that is substantially in alignment with the transverse tunnel. A cannulated cross-pin is provided. The upper end of the graft loop is secured in the femoral tunnel by passing the cannulated bone pin over the filamentary member and mounting the bone pin in the transverse tunnel. The lower end of the graft loop may be secured in the tibial tunnel by inserting a securement member or device into the tibial tunnel, e.g. an interference screw, thereby completing the reconstruction.
These and other aspects, advantages of the present invention, will become more apparent from the following drawings and accompanying description.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is an illustration of a human knee having a ruptured anterior cruciate ligament.
FIG. 2 is an illustration of the knee ofFIG. 1 having tibial and femoral tunnels drilled in the tibia and femor respectively, and illustrating a drill guide mounted to the knee for drilling a transverse tunnel in the femor to receive a cross-pin.
FIG. 3 illustrates an instrument for inserting a looped filamentary member into the tibial and femoral tunnels.
FIG. 4 illustrates the distal end of the loop insertion instrument in the femoral tunnel with a passing pin inserted into the transverse tunnel.
FIG. 5 illustrates the passing pin capturing a looped segment of the filamentary member from the loop insertion instrument as the loop insertion instrument is withdrawn from the femoral tunnel.
FIG. 6 illustrates the distal end of the passing pin extending out through one end of the transverse tunnel, and the loop segment exiting the transverse tunnel.
FIG. 7 illustrates the knee with a surgical suture loop threaded through the tibial and femoral tunnels, and a graft looped segments of the filamentary member and the suture extending out from the bottom of the tibial tunnel; the passing pin has been moved laterally in the transverse to a side of the femoral tunnel.
FIGS. 8a-cillustrates the graft moved into a position extending out from the tibial tunnel adjacent to the entrance to the tibial tunnel, with the top loop segment being cut with surgical scissors and one end being threaded into openings in the passing pin member.
FIG. 9 illustrates the passing pin moved through the transverse tunnel, with the looped segment cut and having a first cut end mounted to the distal end of the passing pin prior to moving the passing pin and end through the transverse tunnel, while the second cut end is free.
FIG. 10 illustrates the first and second ends of the filamentary member exiting opposite sides of the transverse tunnel with a bottom loop segment extending out through the bottom opening of the femoral tunnel with the top of the graft adjacent to the bottom opening of the femoral tunnel; the passing pin has been removed from the transverse tunnel.
FIG. 11 illustrates a section of the suture exiting the femoral tunnel with the graft member moved into and positioned within both the femoral and tibial tunnels, having the top end of the graft emplaced in the femoral tunnel such that the graft loop opening adjacent to the transverse tunnel. Also shown is the filamentary member being tensioned to straighten and align it with the transverse tunnel to serve as a guide wire.
FIG.12—illustrates a cannulated cross-pin inserted over the guide wire and partially inserted into the transverse tunnel.
FIG. 13 illustrates the cross-pin partially inserted with the distal end in the graft loop opening and underneath the top of the graft loop.
FIG. 14 illustrates the cannulated pin completely screwed into place and engaging the graft and securing the upper end of the graft in a substantially fixed position in the femoral tunnel.
FIG. 15 illustrates the knee after the top end of the end of the graft has been secured in the femoral tunnel and the guide wire removed, and with the bottom end of the graft secured in the tibial tunnel using an interference screw, thereby completing the ACL replacement surgical procedure with the ACL replacement graft secured in both the femoral and tibial tunnels to provide for a reconstructed ACL.
DESCRIPTION OF THE INVENTIONThe terms “anterior cruciate ligament” and the acronym “ACL” are used interchangeably herein.
Referring now toFIGS. 1-15, the novel surgical method of the present invention of replacing a ruptured anterior cruciate ligament to reconstruct a knee is illustrated.FIG. 1 illustrates a typical patient'sknee5 prior to the onset of the surgical procedure. Illustrated is the top15 of thetibia10, the top21 of thefibula20, the bottom61 of thefemur60, as well as thecondylar notch65. Theposterior collateral ligament50 is seen to be present in theknee5. Also seen at the top15 of thetibia10 themeniscal cartilage22.
As seen inFIG. 2, after preparing the patient'sknee5 using conventional arthroscopic surgical procedures, atibial tunnel40 is drilled in a conventional manner through the top15 of thetibia10 to createtibial tunnel40.Tibial tunnel40 haspassage41 havinglower opening43 andupper opening45. Thetibial tunnel40 is drilled using a conventional two-step process with an initial pilot guide drill followed by a subsequent coring reamer to create thetibial tunnel40 havingpassage41. Preferably, the tibial tunnel is positioned in the posterior one-half of the normal attachment site of the ACL. Thetunnel40 is typically debrided of all surrounding debris atlower opening43 andupper opening45, and any sharp edges are chamfered using a conventional bone rasp. Next a conventional offset femoral aiming device (not shown) is inserted throughopening43 and into thetibial tunnel40 such that the distal end of the femoral aimer device extends out through theopening45 at the top of thetunnel40, and the distal end of the femoral aimer device engages a suitable position on thesuperior rim66 of thecondylar notch65. Then a guide pin can be drilled up through thenotch65 and out of theanterior cortex67 of thefemur60. Next afemoral tunnel90 is reamed out using a conventional surgical reamer to accommodate the graft diameter. Thefemoral tunnel90 is seen to havebottom opening91,passage95 andtop opening92. The tunnel is seen to have internal step93 where thepassage95 transitions betweenfirst diameter96 andsecond diameter97. Thetunnel90 is typically debrided of all surrounding debris atbottom opening91 andtop opening92, and any sharp edges are chamfered using a conventional bone rasp.
Next, a transversefemoral drill guide120 is mounted to thetibia10 and thefemur60. Thedrill guide120 is seen to have “L” shapedframe122 havingbottom leg126 and perpendiculartop leg128. Thedrill guide120 is seen to havelongitudinal drill guide130 mounted to thebottom leg126 andhorizontal drill guide140 mounted to thetop leg128. Thelongitudinal drill guide130 is positioned within the tibial andfemoral tunnels40 and90, respectively. Apartial incision141 is made in the skin and the tissue thereunder is bluntly bisected to the lateralfemoral cortex68. Thedrill guide140 is advanced to contact thelateral femoral condyral69. Next, adrill145 is inserted into thetransverse drill guide140 and thetransverse tunnel150 is drilled transversely through thefemoral end61. Thedistal end section132 of thelongitudinal drill guide130 contains anopening134 to receive thedrill145 to provide for appropriate alignment. Thetunnel150 is seen to havepassage155, andopposed end openings151 and152. Theknee5 is now ready to have the replacement ACL graft implanted.
The types of ACL implants that can be used in the method of the present invention include autografts, allografts, xenografts and synthetic grafts. Autografts consists of the patients own ligamentous tissue harvested either from the patellar tendon or from the tendons of the hamstring. Allografts include ligamentous tissue harvested from cadavers and appropriately treated and disinfected, and preferably sterilized. Xenografts include harvested connective tissue from animal sources such as, for example, porcine tissue. Typically, the xenografts must be appropriately treated to eliminate or minimize an immune response. Synthetic grafts include grafts made from synthetic polymers such as polyurethane, polyethylene, polyester and other conventional biocompatible bioabsorbable or nonabsorbable polymers and composites. Thegrafts200 are typically prepared in a conventional manner, optionally whip stitching theends212 of the graft withsurgical sutures220, and folding the graft over by bringing theends212 together to form a loop of graft material having a bottom215, aloop top222 and aloop opening225 as seen inFIGS. 9-14.
Thefilamentary members180 that may be used in the practice of the present invention include any type of flexible, strong biocompatible material. The filaments may be a single unitary fiber or may be of multi-filament construction, for example, braided or woven. The filaments may be made from nylon, polypropylene, polyethylene, polyester, braided, woven and twisted metal and/or malleable alloys and combinations thereof. In a particularly preferred embodiment, thefilamentary member180 is made from nylon. Thefilamentary member180 may be precut with two opposed ends, or may be in the form of an endless loop. It is particularly preferred in the practice of the present invention to utilize the filamentary member in the form of an endless loop that is later cut to provide a filamentary member with two ends.
When using afilamentary member180 in the surgical method of the present invention it is preferably used in the form of an endless loop (seeFIGS. 3-11). The filamentary member is loaded on to aninserter instrument240 having aproximal handle242 and a distal notchedend244 for engaging the loop. The distal notchedend244 of theinserter240 having thefilamentary member180 mounted thereto is then inserted into thebottom opening43 of thetibial tunnel40 and the instrument is moved forward through thepassage41 oftibial tunnel40, out ofupper opening45, through bottom opening91 offemoral tunnel90 and into thepassage95 offemoral tunnel90 adjacent to the intersection with thetransverse tunnel150. Then, a passingpin member250 is inserted into opening152 of the transverse tunnel. The passingpin250 is seen to have anotch252 for receiving and engaging a section of thefilamentary loop member180. The passingpin250 is seen to pass through opening246 in notchedend244. Once a section of themember180 is engaged or captured in thenotch252, theinserter member240 is withdrawn from the femoral andtibial tunnels40 and90, respectively, and theshuttle instrument250 is moved laterally until thenotch252 and the engaged section of thefilamentary member180 exits opening151 of thetransverse tunnel150. At that time, the first top loop section185 ofmember180 is removed from thenotch252 by the surgeon and is maintained outside ofopening151. thebottom loop section187 of thefilamentary member180 is seen to extend down out through the bottom of thetibial tunnel40 throughopening43. Asurgical suture260 is then used to move thegraft200 into place in the tibial andfemoral tunnels40 and90, respectively. The surgeon loops or folds thegraft200 through theopening266 ofsuture loop265 ofsuture260 connected to theproximal end282 of the straightsurgical needle280.Needle280 has distal end285. The suture passes through the eyelet283 of theneedle280. At the same time thetendon graft200 is also looped through the opening186 ofbottom section loop187 of thefilamentary member180. The surgeon then pulls the straightsurgical needle280 up in the direction along the longitudinal axes of the femoral andtibial tunnels40 and90, respectively, such that theneedle280 exits thefemoral tunnel90 throughtop opening92, and the suture loop pulls the distal ortop end222 of thegraft loop200 out of the tibial tunnel and adjacent to opening91 offemoral tunnel90. As thesuture260 pulls thedistal end222 of thegraft200 into and out of thetunnel40, the looped end185 of thefilamentary member180 also moves with thetop end222 ofgraft200 into the space adjacent to theopening91 offemoral tunnel90.
Next, the surgeon cuts the top loop section185 with conventionalsurgical scissors400 to form ends181 and182.End182 of themember180 is then threaded into theeyelets256 and the passingpin member250 is moved horizontally in the opposite direction throughpassage155 oftransverse tunnel150 exiting the transverse tunnel through opening152 on the opposite side oftunnel150 such that theend182 also exits the tunnel, and theends181 and182 of thefilamentary member180 exit through opposite sides of the transverse tunnel150 (throughopenings151 and152, respectively). The passingpin member250 is removed from thetransverse tunnel150.Needle280 andsuture260 are then tensioned and moved throughfemoral tunnel90 such that the top section ofgraft200 is moved intofemoral tunnel90 and the grafttop end222 is located in thefemoral tunnel90 in a fixation position, with opening225 in alignment withpassage155. The ends181 and182 of thefilamentary member180 are tensioned to place thefilamentary member180 in a straight configuration to serve as a guide wire throughtransverse tunnel150 and through graft opening225 for a conventional cannulated cross-pin.
Referring now toFIGS. 12-15, the cross-pin300 is seen to havelumen305 and threadedbone engaging section307. Theend181 of thefilamentary member180 is threaded throughlumen305 of cannulatedcross-pin300, and secured in thehandle325 of the drivinginstrument320 by attachment to theoptional bead member330 havingpassages332 for receiving theend181.Bead member330 is mounted to the end ofhandle325. Theother end182 of thefilamentary member180 is placed in tension by the surgeon while the surgeon screws the cross-pin into thetunnel150 underneath the top222 of thegraft loop200 and throughopening225 thereby securing the upper section of thegraft200 in thefemoral tunnel90. The surgeon then removes the drivinginstrument320 from the cross-pin300, and removes theinstrument320 andfilamentary member180 from thetransverse tunnel150 and the cross-pinning procedure is complete, with thetop end222 of theACL replacement graft220 substantially secured or fixed infemoral tunnel90. Shown ifFIG. 11 is the optional depth stop sleeve390 used to assure the surgeon that thethreads307 are flush against the lateralfemoral cortex68 or slightly buried.
The surgeon then affixes thebottom end215 of thegraft200 in thetibial tunnel40 using a conventional securing device such as aninterference screw340, or other conventional devices such as tibial fasteners, screws and washers, etc. The ACL replacement is now complete, and the surgeon can remove the cannulas and close the incisions about the knee using conventional incision approximating techniques including sutures, tape, glue, staples, etc.
The cross-pins useful in the present invention can be made from a variety of conventional biocompatible materials useful in implants. The materials may be absorbable or non-absorbable. Examples of conventional non-absorbable materials include surgical stainless steel, nickel titanium alloys, ceramics, Delrin, polyethylene, and other non-absorbable polymers including, but not limited to, polypropylene, and Acetal. Examples of bioabsorbable materials include PLA, PGA, polydioxanone, polycaprolactone, copolymers thereof, and the like. The term “natural polymer” refers to polymers that are naturally occurring, as opposed to synthetic polymers. In embodiments where the device includes at least one synthetic polymer, suitable biocompatible synthetic polymers can include polymers selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(etheresters), polyalkylenes oxalaes, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, polyurethanes, poly(ether urethanes), poly(ester urethane) and blends thereof. Suitable synthetic polymers for use in the present invention can also include biosynthetic polymers based on sequences found in collagen, elastin, thrombin, fibronectin, starches, poly(amino acid), poly(propylene fumarate), geletin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, ribonucleic acids, deoxyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides and combination thereof. The devices of the present invention may also be manufactured from conventional biocompatible natural polymers. If desired, the bioabsorbable materials may contain osteoinductive or osteoconductive materials, polymers and blends of polymers including but not limited to calcium hydroxyapatite, tricalcium phosphate, and the like.
The cross-pins of the present invention may be made using a variety of conventional manufacturing processes including machining, molding, etc., and combinations thereof.
The novel anterial cruciate ligament replacement procedure of the present invention has improvements over procedures known in the art. In particular, the combination of the needle and suture to pull the graft into the femoral tunnel along with the suture loop filamentary member to provide for a transverse guide wire provides efficiency in the placement of the top of the graft in the femoral tunnel while minimizing or eliminating damage to the bone in the transverse tunnel that could be caused by pulling up the graft using the filamentary member. At the same time that the graft is emplaced in the femoral tunnel, the filamentary wire is in place in the transverse tunnel to serve as a guide wire for emplacing the cross-pin in the transverse tunnel and through the opening in the graft loop.
Although this invention has been shown and described with respect to detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail thereof my be made without departing form the spirit and scope of the claimed invention.